The nation's First Lady is attractive, accomplished, happily married and the mother of two young girls. At the University of Chicago Medical Center, she had managerial experience in a major hospital system.
She is also black.
Because of her family situation, professional experience and role as America's first lady, Michelle is particularly sensitive to the healthcare needs of minority women.
Unfortunately, her African American ancestry means that she or female family members are likely to face problems with the reproductive system. It is a uniquely African American problem.
For some reason, black women seem more likely to develop fibroids. Almost half of all black women more than 30 years of age have fibroids compared with 20 percent of white women of the same age-group. Interestingly, studies have found a low incidence of fibroids among women in Africa. Overall, however, fibroids tend to occur earlier and grow faster in black women.
From another source: "Almost every black woman you know has a fibroid," says Nelson H. Stringer, M.D., an obstetrician/gynecologist at Rush-Presbyterian-St. Luke's Medical Center in Chicago.
The problem, of course, is not limited only to black women. Some 28 million American women of childbearing age have some incidence of them; of these 8 million are symptomatic.
Here is the problem, as summarized by the Fibroid Foundation:
Uterine fibroids, or leiomyomas, are non-cancerous tumors of the uterus. They are diagnosed in about 30% of women and can cause heavy menstrual bleeding, pelvic pain, frequent urination, and infertility. Excessive menstrual bleeding may lead to anemia and fatigue. Levels of hormones produced by the body, such as estrogen, are thought to influence the occurrence of fibroids.
They are most common during a woman’s reproductive years and tend to shrink after menopause. Black women are three times more likely to be diagnosed with fibroids than white women, develop tumors at earlier ages, and have more severe disease at the time of diagnosis.
Fibroids are the leading indication for hysterectomy among U.S. women of all ages, accounting for over 200,000 hysterectomies and more than 1.2 billion dollars in health care costs each year.
Researchers at Brigham & Women's Hospital in Boston have actually identified the gene which leads to the increased incidence amongst minority women.
No orally administered treatment to deal with the problem is presently on the market.
That is why Michelle, if asked because of her political prominence and hospital management experience, will be inexorably drawn to Repros Therapeutics (NASDAQ:RPRX), a Woodlands, Texas biocap which now has just such a drug in clinical trials before the Food and Drug Administration.
By all accounts, RPRX's Proellex has been successful in shrinking tumors and eliminating discomfort associated with fibroids and endometriosis. Proellex is a selective progesterone receptor moderator; efficacy has been shown in both fibroid and endometriosis trials.
The stock was crushed last week when Repros announced that at the highest dosage under trial, levels of liver enzymes were noted above acceptable levels. The drug is being tested in 50, 25 and 12.5 mg doses; the firm has decided to drop the 50 mg dose from its trials. There was one instance, two years ago, of an elevated liver function at the 25 mg dose, but in that case there were pre-existing conditions which could have caused the problem. There were no instances at the 12.5 mg level.
Interestingly, there was another drug (Asoprisnil) in clinical trials about a year ago. It was dropped from trials as a result of what has been described as endometrial hyperplasia, or the dangerous buildup of endometrial tissues in the patient's body while the drug is in use. (Both drugs cause suspension of the woman's normal menstrual cycle.)
Repros's response to the problem, wholeheartedly endorsed by the FDA, is to put all patients on a three-months-on, one-month-off regimen. Thus it is Mother Nature rather than medical science which cleanses the patient's body every fourth month.
The market here is large: Some 28 million American women are afflicted with fibroid or endometrial problems, of which 8 million are symptomatic. Repros management believes the true market for its drug in North America is 6 million patients. Should it gain FDA approval, it hopes to treat at least 20 percent of them.
That implies revenues of upwards of $1 billion annually.
But as the lovely wife of America's newest president, and the mother of two African American girls, Michelle Obama's concerns are far from monetary. They are to ensure that the women near and dear to her can lead happy and productive lives, safe from the risks that genetics make even more frightening than for the population at large.
The very best investment ideas can be summed up in a sentence or two, concise enough to fit on a matchbook cover. For this one, here goes:
There is at present no orally administered treatment to address fibroids and or endometriosis. Those are conditions which in the US afflict 28 million women, of whom the company sees 6 million as severely enough troubled to be the market. A course of Lupron is $1,200. Proelllex works better. Lupron's side effects are horrific. The only side effects associated with Proellex are increased liver enzymes; and those are not present at lower doses.
Proellex, if approved, will do over $1 billion in US revenues alone, and will vastly improve the lives of countless women, a disproportionate number of them African American.
It is worth a couple times that revenue, and with no more than 30 million shares ultimately outstanding, should be worth more than $70 a share.
Disclosure: I am long the stock.